Validation Engineer CSV
il y a 3 heures
Validation Engineer CSVContracting – Antwerp Verantwoordelijkheden Ontwikkelen, implementeren en uitvoeren van URS-, SIA-, DQ-, IQ-, OQ-, PQ-, RV- en TM-activiteiten.Ontwikkelen, implementeren en uitvoeren van validatiestudies voor cGMP-kritische gecomputeriseerde systemen om naleving van cGMP-, gebruikers- en regelgevingseisen aan te tonen. Dit betreft een hands-on rol.Opstellen van validatiedocumentatie (protocollen en rapporten) en ondersteuning bieden bij de uitvoering van validatieprotocollen voor gecomputeriseerde systemen.Verantwoordelijk voor validatiedocumentatie tot en met goedkeuring en implementatie.Uitvoeren van systeemvalidatie waarvoor industriële precedenten bestaan, maar waarbij interpretatie van standaarden nodig is, in overeenstemming met cGMP, cGLP en Sanofi-procedures.Waarborgen dat de gevalideerde status van gecomputeriseerde systemen te allen tijde voldoet aan cGMP-vereisten.Zorgen dat projecten worden beheerd volgens alle vereiste Sanofi-standaarden en cGMP-regelgeving.Op de hoogte blijven van nieuwe validatieregelgeving en testpraktijken om te blijven voldoen aan of te overtreffen aan cGMP-vereisten. Bieden van technische ondersteuning met betrekking tot actuele FDA- (VS) en EU-validatievereisten.Bijdragen aan de beoordeling van wijzigingen en inschatten of deze impact hebben op de gevalideerde status en bijbehorende validatiedocumentatie.Onderzoeken en oplossen van validatie-issues en afwijkingen.Wij zijn op zoek naar een Validation Engineer met projectervaring in de validatie van softwarepakketten en gecomputeriseerde systemen. Vaardigheden en ervaring Sterke communicatieve vaardighedenIn staat om zelfstandig te werken en snel nieuwe kennis op te nemenIn staat om projecten volgens planning uit te voerenGrondige kennis van Computer Systems Validation (CSV)Volledig begrip van relevante kwaliteits- en compliance-regelgevingVaardig in het analyseren en oplossen van validatieproblemenMinimaal 3 jaar ervaring in de farmaceutische sector en een GMP-omgevingGoede kennis van zowel Engels als NederlandsErvaring met DCS-systemen (Emerson DeltaV) is een pluspunt /Validation, IQ, Communicatie, RV, FDA, Planning, cGMP, OQ, Protocols, Geneesmiddel, SIA, Uitvoering, URS, CSV, Engelse taal, PQ, Onderzoek, Nederlands
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Global Lead IT Computer System Validation
il y a 3 heures
Bruxelles, Belgique Prothya Biosolutions Temps plein🌍 Global Lead – IT Computer System Validation (CSV) Location: Prothya Biosolutions Belgium - Neder-Over-Heembeek (with occasional travel to Amsterdam) Department: IT Reports to: Enterprise IT Architect. Are you a seasoned expert in Computer System Validation (CSV) with a passion for quality, compliance, and innovation in the pharmaceutical industry? At...
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QA CSV specialist
il y a 3 heures
Bruxelles, Belgique BioTalent Temps pleinA key client of BioTalent based in Belgium are looking to onboard a QA CSV specialists for their growing quality assurance unit. This role will be responsible for overseeing all quality assurance activities related to verification (qualification) and validation of computerized systems within the facility. Key responsibilities include: Support projects as a...
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LIMS Subject Matter Expert
il y a 3 heures
Bruxelles, Belgique SMART IT PROS INC Temps pleinLIMS Subject Matter Expert (SME) Opportunity – Seattle, WA My client is seeking a LIMS Subject Matter Expert (SME)to join a global biotech company located near Seattle, Washington . The role will involve ownership of project management for LIMS , including data entry into the system and managing any associated procedural revisions. Role...
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Senior Project Engineer
il y a 3 heures
Bruxelles, Belgique We ARE Renewables Temps pleinMechanical Project Engineer – Offshore Substations We are looking for an experienced Mechanical Project Engineer to support offshore AC substation projects. Tasks & Responsibilities: Mechanical engineering support for offshore AC substations Responsibility for mechanical systems (firefighting, HVAC, cranes & lifting equipment, water systems) ...
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Senior Assurance Engineer
il y a 3 heures
Bruxelles, Belgique iO Associates Temps pleinSENIOR ASSURANCE ENGINEER We are seeking a Senior Assurance Engineer to provide independent technical assurance across complex, mission‑critical systems within a defence and NATO environment. The role operates independently from delivery teams and is focused on providing objective, evidence‑based assurance to support senior and executive...
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Senior Hardware Design Engineer
il y a 3 heures
Bruxelles, Belgique Vivid Resourcing Temps pleinHARDWARE DESIGN ENGINEER - BRUSSELS (BELGIUM) - PERMANENT POSITION The Hardware Design Engineer is responsible for designing, developing, and validating electronic hardware systems for spacecraft, satellites, or space-related equipment. This role involves creating robust, reliable, and high-performance hardware solutions that meet the stringent...
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Automation Engineer | Life Sciences
il y a 3 heures
Bruxelles, Belgique Capgemini Engineering Temps pleinAt Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and...
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Senior Infrastructure
il y a 3 heures
Bruxelles, Belgique Empiric Temps pleinSenior Network Engineer - Long Term B2B/Freelancer - Global Banking Client Long term opportunity to join of our biggest banking clients to support multiple projects as an experienced Network Engineer. Unique opportunity to design, test, automate, and upgrade secure, cloud-ready networks using Juniper technology and modern networking tools to ensure...
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Machine Learning Engineer
il y a 3 heures
Bruxelles, Belgique Montash Temps pleinJob Title Machine Learning Engineer Insurance / Financial Services We are supporting an established organisation within the insurance sector that is expanding its data and machine learning capability. They are seeking a Machine Learning Engineer to design, build, and deploy production-grade ML solutions that support core business functions such as...
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Machine Learning Engineer
il y a 3 heures
Bruxelles, Belgique Montash Temps pleinJob Title Machine Learning Engineer Location Brussels, Belgium (Hybrid or Onsite depending on project requirements) Sector Insurance / Financial Services Overview We are supporting an established organisation within the insurance sector that is expanding its data and machine learning capability. They are seeking a Machine Learning Engineer to design, build,...